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Physical Activity in Pediatric Cancer (PAPEC) (PAPEC)

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ClinicalTrials.gov Identifier: NCT01645436
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Alejandro Lucia, Universidad Europea de Madrid

Brief Summary:
The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC) is to assess the impact of an exercise program intervention in pediatric cancer patients undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention will have a beneficial effect on the study outcomes.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Other: exercise training Not Applicable

Detailed Description:

Sixty patients, of both sexes, children will be recruited for this trial with an age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors). Each participant will be assigned randomly (with blocking on sex) to either intervention or control (usual care) group.

The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.

Primary outcomes [cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test', and '3 m and 10m Time Up and Go tests'), physical activity levels (determined by accelerometry) and quality of life "Child Report Form of the Child's Health and Illness Profile-Child Edition", Adolescent Edition and Parents Report Form )] and secondary outcomes [immune function (immune cell subpopulations, natural killer cells' cytotoxicity), inflammatory profile (blood levels of 47 cytokines) and leukocyte telomere length] will be measured in both groups in the following time points:

(i) before the exercise intervention (immediately after diagnosis and before the start of treatment); (ii) after the exercise intervention (upon termination of neoadjuvant chemotherapy); and iii) after a detraining period (2 months after the intervention).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial
Study Start Date : September 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment (exercise)
combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
Other: exercise training
The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
Other Name: physical activity

No Intervention: control (usual care)
Usual hospital care with no exercise



Primary Outcome Measures :
  1. Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. inflammatory profile [ Time Frame: up to 3 years ]
    blood levels of 47 cytokines (including, among others, interferon (IFN) α2, IFNγ, interleukin (IL)1α, IL1ß, IL1ra, IL2, IL2RA, IL3, IL4, IL6, IL7, IL8, IL9, IL10, IL12, IL13, IL15, IL16, IL17, tumor necrosis factor(TNF)-related apoptosis-inducing ligand, and TNFα.



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors) treated in the Hospital Infantul Niño jesús and residents in Madrid community. -

Exclusion Criteria:

  • age<4 years or >16 years, other tumours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645436


Locations
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Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Alejandro Lucia, MD PhD Universidad Europea de Madrid

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alejandro Lucia, MD PhD, PROFESSOR IN EXERCISE PHYSIOLOGY, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT01645436     History of Changes
Other Study ID Numbers: LUCIA
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by Alejandro Lucia, Universidad Europea de Madrid:
randomized controlled trial
in-hospital exercise
children
cancer